1. 1 Accredited Standards Committee C63 ® - EMC Subcommittee 8 Bob DeLisi Chair 2013-11-14

2. 2 Accredited Standards Committee C63 ® - EMC Membership of Subcommittee 8 No new members, no members removed Total members - 27

3. 3 Accredited Standards Committee C63 ® - EMC Motions No Motions for this meeting

4. 4 Accredited Standards Committee C63 ® - EMC WG -1 C63.18 On-site immunity testing of medical equipment WG Chair completed review of the of IEEE editors resulted in 57 comments which need to be discussed with IEEE editors 3-week recirculation ballot for IEEE BSR9 approval once WG Chair editorial comments are resolved Publication planned for early 2014

5. 5 Accredited Standards Committee C63 ® - EMC WG-2 C63.19 Hearing Aid compatibility Working Group Chair reported that the issue remains active with developments in both the hearing aid and phone communities The hearing aid community would like one “world wide” immunity test procedure and improved test repeatability. The IEC committee is revising the corresponding IEC standard and when they finish their work they would like to explore any differences in test methods and the possibility to harmonize the test procedure. The industry has been conducting round-robin tests and evaluating variations in the test procedure to improve test repeatability. There is work going on at Galludet University, in cooperation with the FDA on improving test repeatability and understanding the correlation between test results and field performance. The work will is also studying a more uniform method of testing immunity in GTEMs.

6. 6 Accredited Standards Committee C63 ® - EMC WG-2 C63.19 Hearing Aid compatibility The work will is also study a more uniform method of testing immunity in GTEMs. ETSI is developing a standard on phone hearing aid compatibility (HAC). The draft quotes C63.19 heavily. The WG recommends ANSI ASC C63 and ETSI explore the potential for a co-published standard instead of having 2 standards.

7. 7 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Edits and comment resolution to IEC 60601-1-2 Edition 4 C63.18 SC7 C63.27 WG on wireless interference and coexistence Significant increase in EMC reviews including medical devices with wireless capability Continued work with the Association for Automatic Identification and Mobility (AIM Global) RFID Experts Group (REG) to draft and validate protocols for testing immunity of medical devices to RFID systems

8. 8 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Following guidance documents were released or drafted Wireless Technology in Medical devices – Final posted August 13, 2013 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft posted June 14, 2013 Design Considerations for Devices Intended for Home Use – Under final development Mobile Medical Applications - Final posted August 13, 2013 Planned participation in the AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings Participation postponed due to government shutdown.

9. 9 Accredited Standards Committee C63 ® - EMC Liaison Reports FDA Report (Summary of on-going work at the FDA) Participating on AAMI Wireless Strategy Task Force and there will be coordination with SC7 (wireless coexisting) working group. Working on Ed. 2 of ISO/TS 10974, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device Jeff Silberberg recognized for work on 60601-1-2 and received the IEC1906 award.

10. 10 Accredited Standards Committee C63 ® - EMC Liaison Reports IEC SC62A MT 23 Draft IEC 60601-1-2 4 th Edition Waiting for IEC editor Ballot: two months Estimated publication Early 2014

11. 11 Accredited Standards Committee C63 ® - EMC Liaison Reports AAMI AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings, held October 2013 Topics included IEC 60601-1-2 draft Edition 4 immunity test levels for the Home Healthcare Environment AAMI Representative Report used to report out activities Suggested that SC8 use a similar report out at meetings (to be discussed at future SC8 meeting)